The following data is part of a premarket notification filed by Focus Medical, Llc. with the FDA for Naturalase Lp Nd:yag Laser.
| Device ID | K031828 |
| 510k Number | K031828 |
| Device Name: | NATURALASE LP ND:YAG LASER |
| Classification | Forceps, General & Plastic Surgery |
| Applicant | FOCUS MEDICAL, LLC. 23 FRANCIS J. CLARKE CIRCLE Bethel, CT 06801 |
| Contact | John Lee, Jr |
| Correspondent | John Lee, Jr FOCUS MEDICAL, LLC. 23 FRANCIS J. CLARKE CIRCLE Bethel, CT 06801 |
| Product Code | GEN |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-13 |
| Decision Date | 2003-07-17 |
| Summary: | summary |